BEUDAMED
    FDA Recall Terminated

    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

    Recall: Z-1458-2020 · Initiated February 12, 2020

    Recall

    Recall Number
    Z-1458-2020
    Event Number
    84924
    Firm
    Nextremity Solutions
    FEI Number
    3009540749
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 12, 2020
    Posted
    February 24, 2020
    Terminated
    December 17, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580

    Description

    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

    Reason

    Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant

    Action

    Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.

    Distribution

    International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.

    Quantity

    190 units